After much discussion and debate, on January 6 HRSA finalized its
Final Rule (340B Drug Pricing Program Ceiling Price and Manufacturer
Civil Monetary Penalties Regulation), which supersedes all subparts of
42 C.F.R. Part 10. The revised regulations and preamble language address
key issues in the calculation of 340B ceiling prices (with particular
emphasis on new drugs) and outline the rules under which civil monetary
penalties (CMPs) for “knowing and intentionally” overcharging covered
entities will be imposed.

Key elements and definitions in the Final Rule, including the potential for retroactive application of penalties

Methods for calculating 340B ceiling prices, including the codification of penny pricing

Situational analysis of how new drug pricing will work in practice

The threat of CMPs, how they will be calculated, and under what circumstances they will be imposed by OIG

Other important takeaways for manufacturers’ compliance in 340B

Speaker:John D. ShakowPartnerKing & Spalding

Participants that will find this webinar most beneficial will be
those involved in pharmaceutical companies. Job titles of attendees that
will be most applicable for this session will be: